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A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

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ClinicalTrials.gov Identifier: NCT01813643
Recruitment Status : Terminated (Effects of aripiprazole was not obvious and showed adverse reaction obviously)
First Posted : March 19, 2013
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics,but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Risperidone Drug: Aripiprazole Phase 4

Detailed Description:
Methods:A Multiple-Center, Randomized, Double-Blind.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment
Study Start Date : July 2012
Primary Completion Date : December 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aripiprazole
Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
Drug: Aripiprazole
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
Other Name: Aopai H20041507
Active Comparator: Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.
Drug: Risperidone
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Other Name: Risperdal H20070057


Outcome Measures

Primary Outcome Measures :
  1. The severity of psychosis [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ]
    Positive and Negative Syndrome Scale


Secondary Outcome Measures :
  1. adverse drug reaction [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital ]
    Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale

  2. Clinical general status [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ]
    Clinical general rating scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
  2. Must sign a Information consent form.
  3. Required to provide detailed address and phone number

Exclusion Criteria:

  1. Serious organic disease.
  2. Suicide ideation or hurt others.
  3. Taking antipsychotic within two weeks before.
  4. drug allergy to Risperidone or Aripiprazole.
  5. pregnancy and breastfeeding women.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813643


Locations
China, Hunan
The Second Xiangya Hospital of Central University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Wei Hao
Investigators
Study Director: Wei Hao, MD., Ph.D. Central South University
More Information

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
ClinicalTrials.gov Identifier: NCT01813643     History of Changes
Other Study ID Numbers: 100000-068941
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Wei Hao, Central South University:
Methamphetamine-Associated Psychosis
Aripiprazole
Risperidone

Additional relevant MeSH terms:
Risperidone
Aripiprazole
Methamphetamine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors